Brainstorm Cell Therapeutics (BCLI) Q1 2026 earnings summary

Executive summary

• Focused on developing autologous cellular therapies for neurodegenerative diseases, with NurOwn® as the lead candidate for ALS, PMS, and AD, and advancing the Phase 3b ENDURANCE study in ALS with ongoing regulatory engagement and trial preparations.

• Clinical programs include completed Phase 3 ALS and Phase 2 PMS trials, with site activation and manufacturing readiness for the new Phase 3b trial progressing.

• Recent regulatory milestones include withdrawal of the BLA for NurOwn® in ALS after an FDA advisory committee vote, followed by alignment with the FDA on a Special Protocol Assessment (SPA) for a new Phase 3b trial.

• The company was delisted from Nasdaq in July 2025 due to non-compliance with minimum shareholder equity requirements and now trades on the OTCQB Venture Market.

• Recent $2 million in private placement funding supports near-term operational objectives and trial preparations.

Financial highlights

• Net loss for Q1 2026 was $2.13 million, compared to $2.86 million in Q1 2025; net loss per share improved to $0.19 from $0.45 year-over-year.

• Operating expenses decreased to $2.05 million from $3.09 million year-over-year, driven by lower R&D and G&A costs.

• Research and development expenses were $0.8 million, and general and administrative expenses were $1.3 million for Q1 2026.

• Cash, cash equivalents, and restricted cash totaled $206,000 as of March 31, 2026, with $1.25 million raised in Q1 2026 from private placements and loans.

• Total assets were $755,000 and total liabilities $11.76 million, resulting in a stockholders' deficit of $11.01 million as of March 31, 2026.

Outlook and guidance

• Management expects continued operating losses and negative cash flow from clinical and regulatory activities.

• Additional capital will be required to fund ongoing operations, clinical trials, and commercialization efforts; recent private placements and loans have supplemented liquidity.

• Enrollment for the Phase 3b ENDURANCE trial is contingent on securing additional financing.

• The company is pursuing further regulatory engagement with the FDA for NurOwn® in ALS, with a new Phase 3b trial protocol agreed under SPA.

• Completion of Part A of ENDURANCE is expected to support a new BLA submission for NurOwn.